Phase I Study to Investigate the Alcohol Interaction of DA8159
Phase 1
Completed
- Conditions
- Healthy VolunteersErectile Dysfunction
- Interventions
- Dietary Supplement: Alcohol
- Registration Number
- NCT01241032
- Lead Sponsor
- Asan Medical Center
- Brief Summary
This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Adult males aged 19 to 55 years at screening.
- Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Exclusion Criteria
- Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
- Subjects with hypotension or hypertension.
- Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
- Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Udenafil + Alcohol Alcohol Udenafil 200mg + Alcohol Udenafil Udenafil Udenafil 200mg Udenafil + Alcohol Udenafil Udenafil 200mg + Alcohol
- Primary Outcome Measures
Name Time Method Pharmacokinetics (AUC and Cmax) 48 Hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of